Cognitive Adaptive Training for Improving Medication Adherence, Symptoms, and Function in People With Schizophrenia

This study has been completed.

Sponsor:

The University of Texas Health Science Center at San Antonio

ClinicalTrials.gov Identifier:

NCT00455663

First Posted: April 4, 2007

Last Update Posted: June 15, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Collaborator:

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

Dawn Velligan, The University of Texas Health Science Center at San Antonio

Further study details as provided by Dawn Velligan, The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:

Medication Adherence-pill Count [ Time Frame: 1 final score combined for endpoint for 9 months of treatment and 6 months follow up ]

% medication taken as determined by unannounced pill counts conducted in the home on 2 occasions in each 3 month period. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.

Scores range from 0 to 100 with higher scores reflecting better functioning. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.

Number of Patients Surviving Without Relapse/Exacerbation [ Time Frame: 9 months of treatment 6 months follow up ]

A relapse was scored (only for patients meeting criteria for remission) if scores on any of the 4 items assessing positive symptoms on the Brief Psychiatric Rating Scale increased a minimum of 2 points to a score of 5 or higher, if the patient was suicidal, if the patient was hospitalized, or if the patient was unable to care for themselves without continual supervision

In home treatment using environmental supports such as signs, labels, alarms, checklists and the organization of belongings to bypass cognitive impairment, cue and sequence adaptive behavior and improve a wide range of functional outcomes.

Behavioral: Cognitive Adaptation Training

Environmental supports for all independent living skills

Experimental: Pharm-Cognitive Adaptation Training

Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.

Behavioral: Pharm-Cognitive Adaptation Training

Environmental supports for medication and appointment adherence

Active Comparator: Treatment As Usual

Medication follow up and limited case management provided by local mental health authority

Other: Treatment as usual

Medication follow-up and limited case management provided by local community mental health authority

Detailed Description:

Schizophrenia is a chronic and severely disabling mental disorder. People with schizophrenia may experience hallucinations, delusions, disordered thinking, movement disorders, social withdrawal, and cognitive deficits. Antipsychotic medications have been effective in alleviating many of the symptoms of schizophrenia and improving the lives of people with the disease. It is well established, however, that poor adherence to antipsychotic medications can lead to relapse and rehospitalization. Cognitive deficits often contribute to treatment nonadherence by compromising patients' capacity to establish routines for taking medication. Cognitive adaptation training (CAT) is a treatment approach designed to alter the physical environment of individuals with schizophrenia to compensate for cognitive deficits and improve adaptive function. For example, various environmental supports, such as signs, checklists, and electronic devices, are used to remind patients to take their medication. Studies have shown that CAT's support system led to better treatment outcomes than those produced by standard care in people with schizophrenia. This study will compare the effectiveness of two CAT treatments versus standard treatment in improving medication adherence, symptoms, and function in people with schizophrenia.

After providing a blood sample, participants in this single-blind study will be randomly assigned to Full-CAT, Pharm-CAT, or treatment as usual for 9 months. Participants receiving treatment as usual will not receive CAT support. Full-CAT will entail a comprehensive use of environmental supports to improve multiple areas of adaptive functioning. Pharm-CAT will provide support for medication adherence only. Participants assigned to one of the two CAT groups will receive weekly treatments in their homes. All participants will report to the study site once every 3 months to assess medication adherence, symptomatology, and adaptive functioning. Participants will be interviewed by the study physician for 2 to 3 hours at each visit. A member of the study staff will also visit each participant's home at a random, unannounced time once every 3 months to obtain a blood sample. Follow-up visits will occur 3 and 6 months following the end of treatment.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 60 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Diagnosis of schizophrenia or schizoaffective disorder

If entering the study as an inpatient, hospitalization was recent

Currently receiving treatment with an atypical antipsychotic and continuation on the medication has been recommended

Assumes primary responsibility for taking medication

Currently living in a stable environment

Exclusion Criteria:

History of significant head trauma, seizure disorder, or mental retardation

History of alcohol or drug abuse or dependence within 1 month prior to study entry

History of violence within 6 months prior to study entry

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00455663

Locations

United States, Texas

University of Texas Health Science Center

San Antonio, Texas, United States, 78229-3900

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Dawn I. Velligan, PhD

University of Texas

More Information

Responsible Party:

Dawn Velligan, Professor, Psychiatry, The University of Texas Health Science Center at San Antonio